Mobocertinib (Exkivity) Form

Mobocertinib (Exkivity®) is a kinase inhibitor.
FDA Approved Indication(s) Exkivity is indicated for the treatment of adult patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. ___ Takeda, the manufacturer of Exkivity, will initiate voluntarily withdrawal of Exkivity after post-market data from the EXCLAIM-2 Phase 3 trial revealed Exkivity did not meet the requirements of the FDA Accelerated Approval regulation (see Appendix D). Policy/Criteria
Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Exkivity is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Non-Small Cell Lung Cancer (must meet all):

1. Provider attestation of acknowledgement of Takeda’s request for withdrawal of product due to failure to demonstrate superior progression-free survival (PFS) compared to platinum-based chemotherapy;
2. Diagnosis of locally advanced or metastatic NSCLC;
   
   3. Prescribed by or in consultation with an oncologist;
   4. Age ≥ 18 years;
   5. Disease is positive for epidermal growth factor receptor (EGFR) exon 20 insertion mutations;

3. Member has progressed on or after platinum-based therapy;

   7. For brand Exkivity requests, member must use generic mobocertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
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   CLINICAL POLICY Mobocertinib

4. Request meets one of the following (a or b):
   a. Dose does not exceed both of the following (i and ii): i. 160 mg per day; ii. 4 capsules per day; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
   Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):
5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Non-Small Cell Lung Cancer (must meet all):
7. Provider attestation of acknowledgement of Takeda’s request for withdrawal of product due to failure to demonstrate superior progression-free survival (PFS) compared to platinum-based chemotherapy;
8. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Exkivity for NSCLC and has received this medication for at least 30 days;

9. Member is responding positively to therapy;

   4. For brand Exkivity requests, member must use generic mobocertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
   5. If request is for a dose increase, request meets one of the following (a or b):
      a. New dose does not exceed both of the following (i and ii):
      i. 160 mg per day; ii. 4 capsules per day;
      b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
      Prescribed regimen must be FDA-approved or recommended by NCCN
      Approval duration: 12 months Page 2 of 6

   CLINICAL POLICY Mobocertinib B. Other diagnoses/indications (must meet 1 or 2):

10. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

11. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration
    EGFR: epidermal growth factor receptor NSCLC: non-small cell lung cancer PFS: progression free survival Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Platinum-based chemotherapy (e.g., cisplatin, carboplatin) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Dosing Regimen Varies Dose Limit/ Maximum Dose Varies Appendix C: Contraindications/Boxed Warnings • Contraindications: none reported
    • Boxed warnings: QTc prolongation and Torsades de Pointes Page 3 of 6

    CLINICAL POLICY Mobocertinib Appendix D: Withdrawal from Market • Takeda, the manufacturer of Exkivity, will initiate voluntarily withdrawal of Exkivity after post-market data from the EXCLAIM-2 Phase 3 trial revealed Exkivity did not meet the requirements of the FDA Accelerated Approval regulation. o Exkivity did not meet its primary endpoint of superior PFS compared to platinum- based chemotherapy for NCSLC with EGFR exon 20 insertion mutations. • Exkivity remains available to prescribe while Takeda works with the FDA on withdrawal timing. Takeda will provide updates when and as appropriate. o For additional questions, please contact Takeda at 844-662-8532 or globaloncologymedinfo@takeda.com. V. Dosage and Administration
    Indication NSCLC Dosing Regimen 160 mg PO QD Maximum Dose 160 mg/day VI. Product Availability
    Capsule: 40 mg VII.